Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

European Commission Oks Novartis' Afinitor Tablets For Treatment Of HR+/HER2

Novartis International AG (NVS: Quote) said the European Commission has approved Afinitor (everolimus) tablets for treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

The approval was based on the Phase III BOLERO-2 trial. The randomized, double-blind, placebo-controlled, multi-center study of 724 patients found that treatment with Afinitor plus exemestane more than doubled median progression-free survival, or PFS, to 7.8 months, compared to 3.2 months with exemestane alone, by local investigator assessment.

Besides, an additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months. The most common grade 3-4 adverse reactions were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.

Click here to receive FREE breaking news email alerts for Novartis AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Swiss drug maker Roche Holding said a late-stage trial of its breast cancer drug Kadcyla did not provide superior results compared with an existing therapy. FCA US, until recently known as Chrysler, said Friday it is recalling 257,000 Dodge Ram pickups. The auto maker says the rear axle pinion nut on certain model year 2005 Dodge Ram 1500 trucks may loosen due to an undersized spline on the pinion gear. If the pinion nut loosens, the rear axle may... This medical device company has a very impressive track record of growing business over the past decade. increasing sales from $490.2 million in 2004 to $1.72 billion this year. The Silicone Hydrogel daily disposable lens portfolio constitutes a major avenue for growth.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.